Fscig Hyqvia denied as not medically necessary by Cigna?

Cigna's specific coverage criteria for fscig hyqvia are defined in its own published medical/coverage policy and the FDA-approved prescribing label. A successful appeal documents that your medical records satisfy each criterion those sources list — confirmed diagnosis, any required prior treatments (with dates and outcomes), and clinical severity. If the exact criteria weren't included with your denial, request them in writing; your appeal then maps each requirement to the matching fact in your chart.

## Why Cigna Denies HyQvia on Medical-Necessity Grounds

Cigna's medical-necessity denials for HyQvia in immunoglobulin deficiency typically reflect one of two gaps in the submitted documentation: the record did not clearly establish the diagnosis and severity of the underlying immunodeficiency, or it did not show that the patient's clinical situation meets each specific criterion in Cigna's medical policy for subcutaneous immunoglobulin therapy. Because HyQvia uses a novel delivery mechanism (facilitated SCIG via hyaluronidase), Cigna's reviewers may also apply criteria around why IVIG is not used instead, or why a conventional SCIG product was not selected.

## Why This Denial Is Appealable

Medical-necessity denials are the most frequently appealed — and most frequently overturned — denial category for specialty biologics and immunoglobulin products. Professional society guidance from organizations such as the American Academy of Allergy, Asthma and Immunology (AAAAI) and the Clinical Immunology Society supports immunoglobulin replacement in the appropriate clinical setting, and Cigna's own policy typically aligns with that guidance. A complete, criteria-mapped appeal resolves most submission gaps.

## Federal Appeal Framework

• Internal appeal: File under ERISA §503 and ACA §2719 within the deadline on your denial notice. Request the specific medical-necessity criteria Cigna applied and which were unmet.
• External review: Available under ACA §2719 after internal exhaustion; approximately four months to file. The external reviewer applies an objective clinical standard, not Cigna's proprietary policy alone.
• Expedited review: If your underlying immunodeficiency creates risk of serious or life-threatening infection, request expedited review in writing with supporting clinical documentation.

## Documentation to Gather

1. Diagnosis confirmation — immunology records, laboratory confirmation of immunoglobulin deficiency or the specific PI diagnosis, and duration of diagnosis. 2. Severity and clinical history — documentation of recurrent infections, hospitalizations, or functional limitations tied to inadequately treated immunodeficiency. 3. Prior immunoglobulin therapy history — if you have previously received IVIG or another SCIG product, provide records of that treatment including route, frequency, tolerability, and reason for transitioning to HyQvia. 4. Clinical rationale for HyQvia specifically — prescriber notes explaining why the facilitated SCIG approach (less frequent dosing, home administration, tolerability) is medically appropriate for your individual situation. 5. Prescriber medical-necessity letter — a letter from your immunologist mapping your clinical findings to each of Cigna's published criteria.

## Criteria-Mapping Structure

Obtain Cigna's current medical policy for HyQvia (available on Cigna's provider portal or by written request). List every coverage criterion. For each, record the chart fact, lab result, or clinical event that satisfies it, with the date and source document. Submit this table as a structured exhibit alongside the appeal letter.